30-day adverse outcomes, re-admissions and mortality following vertebroplasty/kyphoplasty.

OBJECTIVES: Despite vertebral fractures being a common occurrence in elderly osteoporotic individuals, literature remains scant with regards to 30-day outcomes following vertebral augmentation for these injuries. We studied a national database of elderly osteoporotic patients who underwent vertebroplasty and kyphoplasty. PATIENTS AND METHODS: The 2012-2014 ACS-NSQIP database was queried using CPT codes for vertebroplasty (22520, 22521 and 22522) and kyphoplasty (22523, 22524 and 22525). Patients undergoing concurrent spinal fusion and/or laminectomies/laminotomies/laminoplasties were removed from the study. Patients with missing data were also excluded from the study. RESULTS: Following inclusion/exclusion criteria, a total of 2433 patients were included in the study out of which 242(9.9%) underwent vertebroplasty and 2191(90.1%) underwent kyphoplasty. Following adjusted analysis, having a dependent functional health status pre-operatively (OR 1.78; p = 0.010), pre-operative sepsis/SIRS (OR 2.52; p = 0.009), history of COPD (OR 1.62; p = 0.025), disseminated cancer (OR 1.94; p = 0.028), pre-operative wound infection (OR 3.47; p = 0.003) and inpatient admission status (OR 3.22; p < 0.001) were independent predictors of having any complication within 30-days of the procedure. Significant independent risk factors for 30-day mortality were functional health status prior to surgery (OR 2.92; p = 0.002), pre-operative dialysis use (OR 11.74; p = 0.003), Disseminated cancer (OR 7.09; p < 0.001), chronic steroid use (OR 3.59; p < 0.001), and inpatient admission status (OR 4.95; p < 0.001). CONCLUSION: Vertebroplasty/Kyphoplasty is associated with significant adverse outcomes. Providers can utilize these data to better pre-operatively filter high-risk patients and tailor an appropriate peri-operative medical optimization program to enhance care to lower the risk of complications, readmissions and mortality from this procedure.

Morbidity, mortality, and readmission after vertebral augmentation: analysis of 850 patients from the American College of Surgeons National Surgical Quality Improvement Program database.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To identify risk factors for poor short-term outcomes after vertebral augmentation procedures. SUMMARY OF BACKGROUND DATA: Vertebral compression fractures are the most common fractures of osteoporosis and are frequently treated with vertebroplasty or kyphoplasty. There is a shortage of information about risk factors for short-term, general health outcomes after vertebral augmentation in the literature. METHODS: Patients older than 65 years who underwent vertebroplasty or kyphoplasty in 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Patient characteristics were tested for association with 30-day adverse events, mortality, and readmission using bivariate and multivariate analyses. RESULTS: A total of 850 patients met inclusion criteria. The average age was 78.9±11.7 years (mean±standard deviation) and females made up 70.8% of the cohort. Of these patients, 9.5% had any adverse event (AAE), and 6.6% had a serious adverse event (SAE). Death occurred in 1.5% of patients, and 10.8% were readmitted within the first 30 postoperative days.On multivariate analysis, AAE and SAE were both significantly associated with American Society of Anesthesiologists class 4 (AAE: odds ratio [OR]=2.7, P=0.013; SAE: OR=2.5, P=0.040) and inpatient status before procedure (AAE: OR=2.7, P<0.001, SAE: OR=2.4, P=0.003). Increased postoperative mortality rate was associated with American Society of Anesthesiologists class 4 (OR=6.4, P=0.024) and the use of nongeneral anesthesia (OR=4.0, P=0.022). Readmission was associated with history of pulmonary disease (OR=2.0, P=0.005) and inpatient status before procedure (OR=1.9, P=0.005). CONCLUSION: Adverse general health outcomes were relatively common, and the factors identified in the earlier text associated with patient outcomes after vertebral augmentation may be useful for preoperative discussions and counseling. LEVEL OF EVIDENCE: 3.

Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data.

STUDY DESIGN: Observational study. OBJECTIVE: Examine the overall survival and treatment costs from a third-party-payer perspective for patients with osteoporotic vertebral compression fractures (OVCFs) treated by vertebral augmentation or conservative treatment in Germany. SUMMARY OF BACKGROUND DATA: OVCFs are associated with increased morbidity, mortality and thus reduced quality of life. Vertebral augmentation has been shown to be effective in these fractures. The association between treatment and survivorship as well as cost per life year gained for balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) was analyzed in the Medicare population. Replication of these analyses is warranted for confidence in findings. METHODS: Claims data from a major health insurance fund were used. Mortality risk differences between operated (BKP, PVP) and nonoperated cohorts were assessed by Cox regression. Operated patient groups were established by propensity score matching adjusting for covariates. For the matched operated patients with OVCF, (2006-2010) survival was estimated by Kaplan-Meier method. RESULTS: A total of 598 newly diagnosed patients with OVCF were operated of 3607 patients with OVCF. The operated cohort was 43% less likely to die than the nonoperated one in the 5-year study period (hazard ratio = 0.57; P < 0.001). Patients who received BKP had higher 60-month adjusted survival rate (66.7%) than those who received PVP (58.7%) (P = 0.68). Cumulative 4-year mean overall costs after first diagnosis were lower for the BKP cohort (PVP: €42,510 vs. BKP: €39,014). Initial upfront higher costs driven by surgical treatment for patients who received BKP are offset by considerable pharmacy costs in patients who received PVP. There were differences between the values of painkiller consumption (PVP: €3321 vs. BKP: €2224). CONCLUSION: Results suggest a higher overall survival rate for operated than nonoperated patients with OVCF and indicate a potential survival benefit for patients who received BKP compared with patients who received PVP. The reasons merit further investigation. Total costs were lower after 4 years for patients who received BKP versus PVP due to less consumption of pharmaceuticals. LEVEL OF EVIDENCE: 3.

Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population.

BACKGROUND: The treatment of vertebral compression fractures with vertebral augmentation procedures is associated with acute pain relief and improved mobility, but direct comparisons of treatments are limited. Our goal was to compare the survival rates, complications, lengths of hospital stay, hospital charges, discharge locations, readmissions, and repeat procedures for Medicare patients with new vertebral compression fractures that had been acutely treated with vertebroplasty, kyphoplasty, or nonoperative modalities. METHODS: The 2006 Medicare Provider Analysis and Review File database was used to identify 72,693 patients with a vertebral compression fracture. Patients with a previous vertebral compression fracture, those who had had a vertebral augmentation procedure in the previous year, those with a diagnosis of malignant neoplasm, and those who had died were excluded, leaving 68,752 patients. The patients were stratified into nonoperative treatment (55.6%), vertebroplasty (11.2%), and kyphoplasty (33.2%) cohorts. Survival rates were compared with use of Kaplan-Meier analysis and Cox regression. Results were adjusted for potential confounding variables. Secondary parameters of interest were analyzed with the chi-square test (categorical variables) and one-way analysis of variance (continuous variables), with the level of significance set at p < 0.05. RESULTS: The estimated three-year survival rates were 42.3%, 49.7%, and 59.9% for the nonoperative treatment, vertebroplasty, and kyphoplasty groups, respectively. The adjusted risk of death was 20.0% lower for the kyphoplasty group than for the vertebroplasty group (hazard ratio = 0.80, 95% confidence interval, 0.77 to 0.84). Patients in the kyphoplasty group had the shortest hospital stay and the highest hospital charges and were the least likely to have had pneumonia and decubitus ulcers during the index hospitalization and at six months postoperatively. However, kyphoplasty was more likely to result in a subsequent augmentation procedure than was vertebroplasty (9.41% compared with 7.89%; p < 0.001). CONCLUSIONS: Vertebral augmentation procedures appear to be associated with longer patient survival than nonoperative treatment does. Kyphoplasty tends to have a more striking association with survival than vertebroplasty does, but it is costly and may have a higher rate of subsequent vertebral compression fracture. These provocative findings may reflect selection bias and should be addressed in a prospective, direct comparison of methods to treat vertebral compression fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Percutaneous vertebroplasty and kyphoplasty for pathologic vertebral fractures in the Medicare population: safer and less expensive than open surgery.

PURPOSE: To compare cost and outcomes of surgical and percutaneous treatments of pathologic vertebral fractures. MATERIALS AND METHODS: Standard Medicare 5% anonymized inpatient files (1999-2009) were retrospectively reviewed. Patients with a diagnosis of vertebral fracture without spinal cord injury and primary or metastatic bony malignancy were divided into percutaneous or surgical groups based on whether they received vertebroplasty/kyphoplasty or surgical treatment. Patients who had no intervention or both interventions were excluded. Cost, length of stay, and type of discharge were examined while controlling for demographic and comorbidity variables. RESULTS: A total of 451 patients were included; 52% received percutaneous treatment and 48% received surgery. Patients treated percutaneously were older (P < .001) and more likely to be female (P = .04). Percutaneous therapy predicted $14,862 less Medicare cost and $13,565 less overall cost (P < .001 for both), and 4.1 fewer inpatient days (P < .001). Patients who underwent surgery had higher odds of death (odds ratio = 3.38, P = .016), discharge to a rehabilitation facility (odds ratio = 3.3, P = .003), and transfer to another inpatient facility (odds ratio = 8.53, P < .001), and lower odds of discharge to home (odds ratio = 0.42, P < .001) and hospice (odds ratio = 0.08, P = .002). CONCLUSIONS: In a Medicare population with bony malignancy and vertebral fractures, percutaneous therapy predicted significantly reduced cost and length of stay versus surgery. Patients who underwent percutaneous therapy were significantly less likely to die, be transferred, or be discharged to rehabilitation facilities, and were more likely to be discharged to home or hospice.

Comparison of unipedicular and bipedicular kyphoplasty on the stiffness and biomechanical balance of compression fractured vertebrae.

Percutaneous kyphoplasty (PKP) has been used to treat osteoporotic vertebral compression fractures for over 10 years; however, clinically speaking it is still controversial as to whether the use of unipedicular PKP or bipedicular PKP is best. Our study aimed to compare the different effects of unipedicular PKP and bipedicular PKP on the stiffness of compression fractured vertebral bodies (VBs), as well as to assess how cement distribution affect the bilateral biomechanical balance of the VBs. During this study, 30 thoracic VBs were compressed, creating vertebral compression fracture models; then they were augmented by unipedicular (group A and B) PKP and bipedicular (group C) PKP. In group A (unipedicular PKP), the cement was injected into one side and the augmentation was limited to the same side of the VB. In group B (unipedicular PKP), the cement was injected at only one side but the augmentation extended across the midline and filled both sides of the VB. In group C (bipedicular PKP), the cement was injected into both sides and thus achieved the bilateral augmentation. For the unipedicular PKP, the amount of cement injected was 15% of the original VB volume; while in bipedicular PKP, the amount of cement injected was a total of 20% of the original VB volume (10% was injected into each side). Using a MTS-858, we examined three phases of the VBs (intact, pre-augmented, post-augmented), by applying loads axially to the total vertebra and bilateral sides of the vertebra for each of three cycles, respectively. The changes of force and displacement were then recorded and the stiffness of the total vertebra and bilateral sides of the vertebra were calculated. For the pre-augmentation stage, the total VB stiffness of groups A, B and C significantly decreased when the compression fracture models were established (P < 0.05). After the cement augmentation (the post-augmentation stage), both groups A and B, showed that the stiffness could be restored to the initial, intact state; however, in group C, the stiffness was significantly higher than the initial, intact state (P < 0.01). The stiffness of the augmented side of group A was significantly higher than the non-augmented side (P < 0.001). In groups B and C, no significant differences were observed in the stiffness between total VB and each individual side. Thus, we can conclude that both unipedicular PKP and bipedicular PKP significantly increase the total VB stiffness. Bipedicular PKP creates stiffness uniformly across both sides of the vertebrae, while unipedicular PKP, creates a biomechanical balance depending on the distribution of cement. If bone cement is augmented only on one side, the stiffness of non-augmented side will be significantly lower than the augmented side, which might lead to an imbalance of stress on the VB. However, when cement augmentation crosses the midline, stiffness of both sides increase comparatively and biomechanical balance is thus achieved.